FDA
RUSH81 Prosthetic Foot
Product Usage: Prosthetic foot for human use
Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.
Ability Dynamics sent an Urgent Medical Device Correction Notice letter dated June 2, 2014 to all affected customers (Prosthetist) who purchased the RUSH Prosthetic Foot. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to fill out the Bracket Bolt Replacement Form and return to Ability Dynamics. Customers with questions are instructed to contact Rich Sainz, National Clinical Manager, 2082 E. University Dr. Tempe AZ 85281 (480) 717-1412, rsainz@abilitydynamics.com.